Peppermint Aroma and Physiological Parameters

Mechanical Ventilation Complication Clinical Trial

Official title:

Effect of Peppermint Aroma on Physiological Parameters of Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05541809
• Other study ID #: 1532020
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Three drops of peppermint oil will be dropped on a cotton ball that will be fixed in the patient's collar. In the placebo group, peppermint oil will be replaced with water.

Description:

Mechanical ventilathetion increases the anxiety of critically ill patients. The physiological parameters of those patients are affected by stress. Peppermint inhalation reduces stress and improves physiological parameters in many studies, but none of these studies used peppermint inhalation on mechanically ventilated patients.

Patients who are conscious on mechanical ventilation via endotracheal via tube will be randomly assigned to two groups. Patients will be kept intubated and mechanically ventilated. Nothing will be changed in patients' mechanical ventilation data. The intervention group will receive peppermint inhalation intervention, and the placebo group received water inhalation intervention. Patients in both groups will be assessed for their smell ability by Sniffin Sticks-test before starting the interventions.

Three drops of undiluted peppermint oil will be dropped on a cotton ball. Then it will be placed about 20 cm from the patient's nose. It will be fixed on the patient's collar. In the placebo group, the cotton ball will be soaked in water. Then, patients will be monitored for one hour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 30, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria: Patients with

• (1) endotracheal tube (ETT)

• (2) mechanical ventilation with spontaneous breathing modes which are CPAP, PIPAP and PSV

• (3) FOUR score equal to or more than 13,

• (4) RASS score from -1 to +4.

Exclusion Criteria: Patients with

• (1) respiratory asthma

• (2) chronic obstructive pulmonary disease

• (3) acute respiratory distress syndrome,

• Sniffin' Sticks-test score of smell less than 17

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Other:
• Aromatherapy
Peppermint aroma inhalation
• Placebo
Water inhalation

Locations

Country	Name	City	State
Egypt	Alexandria University, Faculty of nursing	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	The number of heart beats in one minute. It will be reported in beat per minute.	Change from baseline heart rate at one hour.
Primary	Respiratory rate	The number of breaths in one minute. It will be reported in breath per minute.	Change from baseline respiratory rate at one hour.
Primary	Mean blood pressure	Mean blood pressure equal diastolic blood pressure + 1/3 [systolic blood pressure - diastolic blood pressure]. It will be reported in millimeters of mercury (mmHg).	Change from baseline mean blood pressure at one hour.
Primary	Pain score	It will be measured using non verbal pain assessment scale. It consists of five categories; face, movement, guarding, physiology, and respiratory items. It will be reported in score. The maximum score of the scale is 10 which means extremely sever pain, and the minimum score is zero which means no pain.	Change from baseline pain score at one hour.